I. Field of the Invention
The present disclosure relates generally to salts of α-tocopheryloxyacetic acid (α-TEA), polymorphic forms thereof, and pharmaceutical compositions thereof. In other aspects, the present disclosure also relates methods for preparation and use of these substances.
II. Description of Related Art
Vitamin E analogs such as α-tocopheryloxyacetic acid (α-TEA) have been previously reported (U.S. Pat. Nos. 6,417,223, 6,703,384 B2, 6,770,672 B1, and 7,312,232 B2). The derivative α-TEA has been shown to suppress the growth of tumors through a mechanism which includes mitochondrial depolarization and the generation of reactive oxygen species which trigger cell death (Yu, et. al., 2010; Neuzil, et. al., 2007; Kline, et. al., 2007). Studies have shown that the compound inhibits the growth of a variety of different cancer cell lines without significant negative effects on normal tissues (Lawson, et al., 2003; Anderson, et al., 2004; Hahn, et al., 2009; Hahn, et al., 2006).
In view of these promising biological properties, and in consideration that biological activity profiles and physical properties can be expected vary across different salt forms of a compound, it remains desirable to obtain novel salts forms with advantageous properties, including one that may ease process scale-up and formulation issues and/or possess biological activity or pharmacokinetic profiles that is well suited for the treatment or prevention of a given disease or indication. In view of the high degree of unmet medical need represented by the diseases and indications discussed herein, it is therefore desirable to synthesize new solid forms, including salt forces, of α-TEA.